The Food and Drug Administration & Cosmetics

I’m speaking at The Divine Female, an event from yogitoes and The Yoga Beauty Bar for conscious beauty and breast cancer awareness, on Saturday at 11:30 a.m. about deciphering beauty ingredients. I was talking to my mom about it, and she espoused a view held by many – that the Food & Drug Administration (FDA) makes sure the beauty products we use are safe.

But that assumption is false. In fact, despite the fact that most of us believe the FDA looks out for us, when it comes to cosmetics, it really doesn’t. So I thought I would discuss a bit of background about the FDA.

The FDA is responsible for over-the-counter and prescription drugs and medical devices, biologics, food (except for meat, poultry, egg products, and the labeling of alcoholic beverages and tobacco) and food additives, radiological products, and cosmetics. How the FDA oversees personal care products is the most relevant generally to this blog.

The FDA’s authority over cosmetics is relatively limited. As explained on the FDA’s website, “FDA’s legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices.” FDA does not approve cosmetics ingredients before they are placed on the market, with the exception of certain color additives and a few substances are banned from cosmetics. In fact, the FDA explains

“[i]n general, except for color additives and those ingredients which are prohibited or restricted from use in cosmetics by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic provided that the ingredient and the finished cosmetic are safe, the product is properly labeled, and the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.”

The list of prohibited or restricted ingredients is amazingly short. In comparison, the European Union list of prohibited or restricted chemicals is over 1,100 chemicals, although some of the chemicals would never be found in cosmetics.

Who determines whether a cosmetic is safe? As explained on the FDA’s website, “[c]osmetic firms are responsible for substantiating the safety of their products and ingredients before marketing,” and not the FDA. In other words, no independent agency determines whether a product is safe. In fact, the FDA doesn’t even define the criteria. While the regulations provide that each ingredient must be adequately substantiated for safety prior to marketing, the FDA doesn’t provide clear guidance as to the meaning of “adequately substantiated” or “safety” for cosmetics. If cosmetic companies don’t adequately substance a cosmetic product’s safety before marketing it, they are required to include on the label the following statement: “Warning – The safety of this product has not been determined.” But if there are no definitions or guidance, how does a company even determine whether a product complies? In fact, the Environmental Working Group (“EWG”) states that it reviewed more than 20,000 cosmetic product labels and did not find a single one with the statement. I’ve never seen such a statement either.

Of course, this doesn’t mean that cosmetics are inherently unsafe. But, at least one study concluded that approximately 89% of the ingredients routinely used in cosmetics have not been assessed by the FDA or the industry. According to the EWG, 98% of all personal care products contain one or more ingredients never publicly assessed for safety.

Who does review cosmetics ingredients? The companies manufacturing beauty products may privately conduct their own assessments. The cosmetics industry also relies upon the Cosmetic Ingredient Review (“CIR”). The CIR was created by the cosmetic industry trade group to police the industry. The CIR is funded by the member companies of the Cosmetic, Toiletry and Fragrance Association and its recommendations regarding safety are just that, recommendations, not requirements, and can be ignored. Also, the CIR’s focus is whether a cosmetic ingredient causes irritation or allergic reactions, not carcinogenicity or reproductive or developmental toxicity. For an illuminating discussion of the CIR and the cosmetics industry, I highly recommend Stacy Malkan’s book, Not Just a Pretty Face: The Ugly Side of the Beauty Industry.

Not only does the FDA have no authority to approve cosmetics ingredients before products hit the market, the FDA is not authorized to require recalls of cosmetics.

The FDA is also responsible for food contact substances. FDA’s regulation of food contact substances is also relevant to this blog (think BPA for example). Food contact substances are those items that are not directly added to food, but are in contact with food, such as packaging materials. If a new food contact substance is proposed, or a new use of an existing food contact substance is proposed, a manufacturer must give the FDA notice of it unless there are existing regulation related to the used or the substance or use is considered “Generally Recognized as Safe” (or “GRAS”).

This voluntary GRAS notification program was proposed in 1997. In 1997, the FDA abolished its existing procedure by which it approved petitions to designate substances because the FDA did not have the resources to review and approve the petitions. Under the GRAS notification process, a manufacturer informs the FDA that it has determined that a substance or use is GRAS, as opposed to petitioning the FDA to approve the use or a substance is GRAS. As explained by the FDA, if the manufacturer’s determination is correct, the use or the substance is not subject to any legal requirement for FDA review and approval. In fact, since the GRAS notification process is voluntary, a manufacturer may market the substance or use without informing FDA if the manufacturer determines it is GRAS or, if FDA is so informed, while FDA is reviewing that information. Sounds crazy, doesn’t it? As long as a manufacturer determines the food contact substance or use is GRAS, it can go ahead and market it.

What is “safe” for these regulations? According to the implementing regulations, the term “safe” means “that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. It is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance. Safety may be determined by scientific procedures or by general recognition of safety.”

So how does this voluntary GRAS notification process work? Let’s look at one potentially relevant example. If you’ve used or are using formula, you probably know some manufacturers supplement their infant formula with DHA and ARA. But, some manufacturers use DHA and ARA extracted from laboratory-grown fermented algae and fungus and processed with hexane, known as DHASCO and ARASCO, although not identified as such on the list of ingredients. DHASCO and ARASCO are structurally different from the DHA and ARA found in breast milk. The manufacturer of DHASCO and ARASCO submitted a notice to the FDA stating that DHASCO and ARASCO added to infant formula are GRAS. The FDA responded to the notice that it had no further questions. DHASCO and ARASCO are currently marketed in infant formula. But, the FDA and the manufacturer recognize that some infants have adverse reactions from consuming infant formula with DHASCO and ARASCO such as diarrhea, bloating, vomiting, jaundice, apnea, flatulence, and other gastrointestinal problems. Nevertheless, the manufacturer maintains they are GRAS, so the manufacturer is free to market them. And these infant formula products are not labeled to indicate the presence of DHASCO and ARASCO (as opposed to DHA and ARA), so you can’t tell when buying formula.

So that is a bit about the FDA. More information to come on deciphering beauty ingredients.